Jazz Pharmaceuticals (JAZZ) and partner Concert Pharmaceuticals, Inc. (CNCE) announced the initiation of a phase I study (n=28) on JZP-386, a deuterated version of sodium oxybate (the active ingredient in Xyrem). Xyrem is marketed by Jazz Pharma in the U.S. for the treatment of cataplexy and excessive daytime sleepiness in patients suffering from narcolepsy.
The phase I study will be evaluating the safety, pharmacokinetics (:PK), and pharmacodynamics (PD.TO) of JZP-386. The study will also include Xyrem as an active control. The primary objective of the study is to identify safe and tolerable dose/doses of JZP-386 to be used in subsequent clinical studies. Jazz Pharma will also evaluate whether JZP-386 is appropriate for once nightly dosing.
We remind investors that Jazz Pharma and Concert Pharma collaborated in 2013 as per which the former gained the worldwide rights to develop and commercialize JZP-386. Concert Pharma, responsible for clinical activities of JZP-386 through phase I, is eligible to receive milestone payments and tiered royalties on any worldwide sales.
Xyrem contributed around 65.8% ($569.1 million) of net product sales of Jazz Pharma last year. Jazz Pharma is facing a series of patent challenges on the drug. The company is currently engaged in several litigations with generic drug makers of Xyrem. The sooner-than-expected entry of Xyrem generics would be a huge blow for the company.
The development of JZP-386 is primarily to protect Xyrem revenues. As a result, the successful development of JZP-386 is crucial for Jazz Pharma. The company’s shares gained around 2.8% on the announcement of phase I study initiation on JZP-386.
Jazz Pharma holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Synergy Pharmaceuticals, Inc. (SGYP) and Actelion Ltd. (ALIOF). Both the stocks hold a Zacks Rank #1 (Strong Buy).
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